EMMA: Empowerment, Motivation and Medical Adherence
试验速览
- 阶段
- 不适用
- 入组人数
- 270
- 试验地点
- 2
- 主要终点
- HbA1c
研究概览
简要总结
EMMA: Empowerment, Motivation and Medical Adherence. A consultation program based on dialogue tools for adults with poorly regulated Type 2 diabetes.
详细描述
Traditionally, the success of patients to manage their diabetes has been judged by their ability to adhere to a prescribed therapeutic regimen, and efforts have been spent developing strategies to promote adherence. It is estimated that 20% to 50% of patients with chronic conditions are not adherent to their prescribed medication regimen, with non-adherence being defined as <80% adherence to prescribed, relevant medication. The treatment regimen often comprises several elements such as poly-pharmacy including insulin administration, self-monitoring of blood glucose, diet and physical exercise. It is thus not just a matter of 'taking a pill or not' but implies lifestyle changes, knowledge and competence, and internal motivation for self-management. The investigators developed a consultation program based on dialogue tools. The EMMA program aims to support medication adherence and blood glucose control by facilitating rapport, exploring patient concerns and challenges, enabling knowledge exchange and supporting goal-setting and action-planning. A pilot test of the program appeared feasible and acceptable to patients and health care professionals and showed significant decrease on HbA1c. EMMA is now ready to be tested in a randomized controlled study (RCT) study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults Type 2 diabetes ≥ 18 år
- •Type 2 diabetes ≥ 1 år
- •HbA1c ≥ 64 mmol/mol (≥ 8%) at the last three measures before randomisation
- •Taking medication for Type 2 diabetes • - Speak, read and understands Danish
排除标准
- •Participating in other intervention research projects during the trial period
- •Being treated by a psychiatrist or psychologist during the period
- •Reduced sight or blindness
结局指标
主要结局
HbA1c
时间窗: Baseline, 4½ month and 6 months after end of intervention period
Change from baseline in HbA1c at 4½ month which is maintained or improved at 6 months
次要结局
- Self-management(Baseline, 4½ month and 6 months after end of intervention period)
研究者
Gitte Reventlov Husted
Researcher PhD
Steno Diabetes Center Copenhagen
